Frequently Asked Questions

Frequently Asked Questions

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What qualified clinical trial cost types are not billable to the study subject or his/her insurance and must be paid by study sponsor?

The following qualified clinical trial cost types are not billable to the study subject or insurance, and should be paid by the study sponsor or covered by other appropriate funding source:

Any item/service that is:

promised free in the informed consent

customarily provided by the research sponsor free of charge for any enrollee in the trial

The investigational item/service that is the objective of the clinical trial unless it is otherwise covered outside the study or by other CMS coverage determination.

Protocol activity/items/services that are not for the direct clinical safety and management of the subject at the time of the order (e.g., consent, inclusion/exclusion labs/imaging/services, research-only protocol activity, monthly CT scans for a condition usually requiring only a single scan).